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  • Title: [Tolerance and efficiency of intravesical instillation of Calmette-Guérin in the prophylactic treatment of superficial bladder tumors, using a maintenance treatment].
    Author: Saint F, Irani J, Salomon L, Debois H, Abbou CC, Chopin D.
    Journal: Prog Urol; 2001 Sep; 11(4):647-56. PubMed ID: 11761685.
    Abstract:
    UNLABELLED: Maintenance treatment with complementary BCG instillations in the prevention of superficial bladder tumour could improve the results of this immunotherapy. This maintenance treatment is limited by accentuation of the adverse effects related to BCG. OBJECTIVES: To evaluate the impact of maintenance treatment on tumour recurrence and progression, and to evaluate the influence of adverse effects on maintenance treatment and the recurrence rate. MATERIAL AND METHODS: 72 patients were treated with six weekly instillations of 81 mg of BCG (Immucyst) followed by three complementary instillations 3, 6, 12, 18, 24, 30 and 36 months later. Adverse effects (AE) were classified into four classes, according to their type, severity and duration, and were recorded prospectively for 518 instillations. An adverse effect score was determined for each patient. RESULTS: 84.9% of patients did not present any recurrence, 12.5% developed recurrence and 2.6% progressed. The instillation regimen was completed by 19% of patients, the dose had to be decreased for 57% of patients and treatment had to be discontinued for 39% of patients. An initial adverse effect score (AESi) greater than 1.5 was associated with an increased risk of discontinuation of treatment or reduction of the dosage during maintenance treatment (p = 0.01). CONCLUSIONS: Maintenance treatment was associated with a very low recurrence and progression rate. We have established and validated an adverse effect severity scale and the consequences of these adverse effects on maintenance treatment. This scale could be used to prospectively define the most appropriate maintenance instillation regimen, by preventively decreasing the doses or deferring instillation.
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